FDA OKs Afinitor Disperz for Child Brain Tumors

WASHINGTON -- The Food and Drug Administration on Wednesday
cleared a new formulation of Novartis drug Afinitor to treat very
young patients with brain tumors caused by a rare genetic
disorder.

The new formulation, Afinitor Disperz, was cleared to treat
children as young as 1 year old who have inoperable tumors caused
by tuberous sclerosis.

Tuberous sclerosis causes tumors in the brain, eyes, lungs,
liver and other organs, leading to learning disabilities, seizures
and other problems. The tumors are not cancerous, but they can be
fatal for patients who develop complications from tumor growth in
the brain.

The drug was previously approved for children 3 years old and
up.

The FDA approved Afinitor Disperz for very young patients who
have brain tumors called subependymal giant cell astrocytoma that
can't be treated with surgery.

Afinitor is also approved to treat various types of lung,
pancreatic and kidney cancers. The drug blocks a protein that plays
a role in uncontrolled tumor growth.

Afinitor was cleared under the FDA's accelerated approval
program, which allows approval of new drugs based on preliminary
clinical trial results. Companies are required to conduct
additional studies to confirm the benefits of their drugs.

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